FDA.reportPublic FDA data

MEDLINE

Primary DI
10653160395553
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
DYNDA3035A
Catalog number
DYNDA3035A
Device description
WOUND CARE KIT
Published
2026-10-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LROGeneral surgery tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213481000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213481000Medline General Surgery TrayMedline Industries, Inc.2022-05-24LRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00653160395556PackageGS150In Commercial Distribution
10653160395553PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160395556006531603955566531603955560653160395556
1065316039555310653160395553

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20080196921277GeminiGEM2140GEM21402016-10-14
10197344148462MEDLINERTDCIHCMGRTDCIHCMG2026-10-30
10197344148479MEDLINERTDCIHCMNRTDCIHCMN2026-10-30
10197344148486MEDLINERTDCIHCMPRTDCIHCMP2026-10-30
10197344148493MEDLINERTDCIHCMRRTDCIHCMR2026-10-30
10197344148509MEDLINERTDCIHCMYRTDCIHCMY2026-10-30
10197344148516MEDLINERTDCIHCMZRTDCIHCMZ2026-10-30
10197344148523MEDLINERTDCINCMBRTDCINCMB2026-10-30
10197344148530MEDLINERTDCINCMGRTDCINCMG2026-10-30
10197344148547MEDLINERTDCINCMNRTDCINCMN2026-10-30
10197344148554MEDLINERTDCINCMPRTDCINCMP2026-10-30
10197344148561MEDLINERTDCINCMRRTDCINCMR2026-10-30
10197344148578MEDLINERTDCINCMYRTDCINCMY2026-10-30
10197344219612MEDLINESTAPLER35PGXSTAPLER35PGX2026-10-30
10197344227471MEDLINEDYNCCDS12DYNCCDS122026-10-30
10197344227488MEDLINEDYNCCDS12TDYNCCDS12T2026-10-30
10197344227495MEDLINEDYNCCDS14DYNCCDS142026-10-30
10197344227501MEDLINEDYNCCDS14TDYNCCDS14T2026-10-30
10197344227518MEDLINEDYNCCDS16DYNCCDS162026-10-30
10197344227525MEDLINEDYNCCDS16TDYNCCDS16T2026-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160542323HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542330HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542347HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542354HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542361HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542378HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542385HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542392HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542408HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542422HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542446HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542453HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542460HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542477HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542484HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542507HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542514HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542521HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542538HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542545HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542552HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542569HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542576HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542583HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542590HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542606HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542620HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542637HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542644HalyardAVID MEDICAL, INC.LRO2026-11-02
10809160542651HalyardAVID MEDICAL, INC.LRO2026-11-02